NCT00265993已完成4 期
The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants.
研究概览
简要总结
Study objectives :
- To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors
排除标准
- •Patients with a history of heparin or warfarin treatment longer than 24 hours,
- •Patients requiring thrombolytic treatment,
- •Patients having thrombophilia diagnosis,
- •Patients with prior deep vein thrombosis or pulmonary emboli evidence,
- •Patients with familial bleeding disorder,
- •Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month
- •Patients with renal failure (serum creatinine concentration > 180 mmol/L or > 2.03 mg/dL),
- •Patients with severe hepatic failure
- •Patients with history of allergy against heparin and protamine,
- •Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment,
- •Patients participating in another clinical study within the last 4 months
- •Patients who are pregnant
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
enoxaparin
干预措施: enoxaparin (Drug)
结局指标
主要结局
Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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